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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

Official Title

A Phase 3 Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients With Metastatic Breast Cancer Who Have Stable Brain Metastases and Have Been Previously Treated With an Anthracycline, a Taxane, and Capecitabine

Details

This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

In Group A, NKTR-102 will be administered at a dose level of 145 mg/m2 on a q21d schedule as a 90-minute intravenous (IV) infusion on Day 1 of each treatment cycle. In Group B, TPC will be administered per standard of care. Patients randomized to TPC will receive single-agent IV chemotherapy, limited to choice of one of the following 7 agents: eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel.

This study will randomize approximately 350 patients using a 1:1 randomization ratio and stratification based on geographic region, tumor receptor status, and Eastern Cooperative Oncology Group (ECOG) status. At Screening, the Investigator must determine which TPC will be offered to the patient.

Data will be collected on subsequent anticancer therapies in both treatment groups from the time patients come off the study treatment until the time of primary data analysis for OS.

An independent data monitoring committee (DMC) will assess interim safety and efficacy data.

Keywords

Metastasis Breast Cancer Breast Cancer Brain Metastases (BCBM) Carcinoma Breast Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Paclitaxel Vinorelbine Docetaxel Gemcitabine Taxane Albumin-Bound Paclitaxel Capecitabine

Eligibility

You can join if…

Open to people ages 18 years and up

  • Female or male, age ≥ 18 years.
  • Histologically-confirmed carcinoma of the breast (either the primary or metastatic lesions) for whom single-agent cytotoxic chemotherapy is indicated. Patients may have either measurable or non-measurable disease according to RECIST version 1.1.
  • Patients must have a history of brain metastases that are non-progressing.
  • For triple-negative breast cancer, a minimum of 1 prior cytotoxic chemotherapy regimen must have been administered for the indication of metastatic disease.Depending on receptor status, 1 or 2 prior cytotoxic regimens are required prior to enrollment in this trial; hormonal and/or human epidermal growth factor receptor 2 (HER2) -targeted agents may be required.
  • Have had prior therapy (administered in the neoadjuvant, adjuvant, and/or metastatic setting) with an anthracycline, a taxane, and capecitabine (prior anthracycline can be omitted if not medically appropriate or contraindicated for the patient).
  • Last dose of anticancer therapy must have been administered within 6 months of the date of randomization into this study.
  • All anticancer- and radiation therapy-related toxicities must be completely resolved or downgraded to Grade 1 or less (neuropathy may be Grade 2 or less).
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Demonstrate adequate organ function obtained within 14 days prior to randomization and analyzed by the central laboratory.
  • Women of childbearing potential (WCBP) must agree to use highly effective methods of birth control throughout the duration of the study until 6 months following the last dose of study drug.
  • Males with female partners of child-bearing potential must agree to use a barrier contraception (e.g., condom with spermicidal foam/gel/film/cream/suppository)throughout the duration of the study until 6 months following the last dose of study drug; in addition to their female partner using either an intrauterine device or hormonal contraception and continuing until 6 months following the last dose of study drug. Male patients should not donate sperm until 6 months following the last dose of study drug.

You CAN'T join if...

  • Last dose of anticancer therapy (including HER2-targeted therapy) within 14 days prior to randomization.
  • High-dose chemotherapy followed by stem cell transplantation (autologous or allogeneic).
  • Major surgery within 28 days prior to randomization.
  • Concomitant use of any anticancer therapy or use of any investigational agent(s).
  • Received prior treatment for cancer with a camptothecin-derived agent.
  • Lesions on imaging, by cerebrospinal fluid or with neurological findings that are consistent with leptomeningeal disease or meningeal carcinomatosis.
  • Chronic or acute GI disorders resulting in diarrhea of any severity grade.
  • Patients who are pregnant or lactating, plan to get pregnant, or have a positive serum pregnancy test prior to randomization.
  • Enzyme-inducing anti-epileptic drugs (EIAEDs) within 14 days of randomization.
  • Hepatitis B or C, tuberculosis, or HIV.
  • Cirrhosis.
  • Prior malignancy (other than breast cancer) unless diagnosed and definitively treated more than 5 years prior to randomization.
  • Daily use of oxygen supplementation.
  • Significant known cardiovascular impairment.
  • Prior treatment with NKTR-102.
  • Psychiatric illness, social situation, or geographical situation that preclude informed consent or limit compliance.
  • Known intolerance or hypersensitivity to any of the products used in this study or their excipients.
  • For patients selecting vinorelbine or gemcitabine as the TPC agent, patients may not receive yellow fever vaccine in the 28 days prior to randomization.

Locations

  • Investigator Site - San Francisco accepting new patients
    San Francisco, California, 94115, United States
  • Investigator Site - Salt Lake City accepting new patients
    Salt Lake City, Utah, 84106, United States
  • Investigator Site - Tucson accepting new patients
    Tucson, Arizona, 85724, United States
  • Investigator Site - Seattle accepting new patients
    Seattle, Washington, 98109, United States
  • Investigator Site - Fort Worth accepting new patients
    Fort Worth, Texas, 76104, United States
  • Investigator Site - Houston accepting new patients
    Houston, Texas, 77030, United States
  • Investigator Site - Minneapolis accepting new patients
    Minneapolis, Minnesota, 55455, United States
  • Investigator Site - Saint Louis accepting new patients
    Saint Louis, Missouri, 63110, United States
  • Investigator Site - Germantown accepting new patients
    Germantown, Tennessee, 38138, United States
  • Investigator Site - Nashville accepting new patients
    Nashville, Tennessee, 37203, United States
  • Investigator Site - Columbus accepting new patients
    Columbus, Ohio, 43210, United States
  • Investigator Site - Athens accepting new patients
    Athens, Georgia, 30607, United States
  • Investigator Site - Orange accepting new patients
    Orange, California, 27599, United States
  • Investigator Site - Chapel Hill accepting new patients
    Chapel Hill, North Carolina, 27599, United States
  • Investigator Site - Baltimore accepting new patients
    Baltimore, Maryland, 21201, United States
  • Investigator Site - West Palm Beach accepting new patients
    West Palm Beach, Florida, 33401, United States
  • Investigator Site - Plantation accepting new patients
    Plantation, Florida, 33324, United States
  • Investigator Site - Miami accepting new patients
    Miami, Florida, 33136, United States
  • Investigator Site - Montreal accepting new patients
    Montréal, Quebec, H4A 3J1, Canada
  • Investigator Site - New York accepting new patients
    New York, New York, 10065, United States
  • Investigator Site - Boston accepting new patients
    Boston, Massachusetts, 02115, United States
  • Investigator Site - Bradford accepting new patients
    Bradford, BD7 1DP, United Kingdom
  • Investigator Site - Manchester accepting new patients
    Manchester, M20 4BX, United Kingdom
  • Investigator Site - Nottingham accepting new patients
    Nottingham, NG5 1PB, United Kingdom
  • Investigator Site - Brussels accepting new patients
    Brussels, 1000, Belgium
  • Investigator Site - Brussels accepting new patients
    Brussels, 1180, Belgium
  • Investigator Site - Brussels accepting new patients
    Brussels, 1200, Belgium
  • Investigator Site - Charleroi accepting new patients
    Charleroi, 6000, Belgium
  • Investigator Site - Edegem accepting new patients
    Edegem, 2650, Belgium
  • Investigator Site - Liege accepting new patients
    Liège, 4000, Belgium
  • Investigator Site - Namur accepting new patients
    Namur, 5000, Belgium
  • Investigator Site - Sint-Niklaas accepting new patients
    Sint-Niklaas, 9100, Belgium
  • Investigator Site - Porto accepting new patients
    Porto, 4200-072, Portugal
  • Investigator Site - Grenoble accepting new patients
    Grenoble, 38700, France
  • Investigator Site - Le Mans accepting new patients
    Le Mans, 72000, France
  • Investigator Site - Nimes accepting new patients
    Nîmes, 30029, France
  • Investigator Site - Paris accepting new patients
    Paris, 75005, France
  • Investigator Site - Rennes accepting new patients
    Rennes, 35042, France
  • Investigator Site - Rouen accepting new patients
    Rouen, 76038, France
  • Investigator Site - Saint-Cloud accepting new patients
    Saint-Cloud, 92210, France
  • Investigator Site - Strasbourg accepting new patients
    Strasbourg, 67091, France
  • Investigator Site - Toulouse accepting new patients
    Toulouse, 31052, France
  • Investigator Site - San Sebastián accepting new patients
    San Sebastián, Gipuzkoa, 20014, Spain
  • Investigator Site - Barcelona accepting new patients
    Barcelona, 8023, Spain
  • Investigator Site - Barcelona accepting new patients
    Barcelona, 8035, Spain
  • Investigator Site - Granollers accepting new patients
    Granollers, 08402, Spain
  • Investigator Site - Jaen accepting new patients
    Jaén, 23007, Spain
  • Investigator Site - Madrid accepting new patients
    Madrid, 28034, Spain
  • Investigator Site - Madrid accepting new patients
    Madrid, 28040, Spain
  • Investigator Site - Santa Cruz de Tenerife accepting new patients
    Santa Cruz de Tenerife, 38320, Spain
  • Investigator Site - Sevilla accepting new patients
    Sevilla, 41009, Spain
  • Investigator Site - Sevilla accepting new patients
    Sevilla, 41013, Spain
  • Investigator Site - Praha accepting new patients
    Praha, 14044, Czechia
  • Investigator Site - Napoli accepting new patients
    Napoli, 80131, Italy
  • Investigator Site - Christchurch accepting new patients
    Christchurch, 8011, New Zealand
  • Investigator Site - Be'er Ya'aqov accepting new patients
    Be'er Ya'aqov, 70300, Israel
  • Investigator Site - Beersheba accepting new patients
    Beersheba, 84101, Israel
  • Investigator Site - Haifa accepting new patients
    Haifa, 31096, Israel
  • Investigator Site - Jerusalem accepting new patients
    Jerusalem, 91120, Israel
  • Investigator Site - Tel Aviv accepting new patients
    Tel Aviv, 64239, Israel
  • Investigatory Site - Albury accepting new patients
    Albury, New South Wales, 2640, Australia
  • Investigator Site - Darlinghurst accepting new patients
    Darlinghurst, New South Wales, 2010, Australia
  • Investigator Site - Wollongong accepting new patients
    Wollongong, New South Wales, 2500, Australia
  • Investigator Site - Subiaco accepting new patients
    Subiaco, Western Australia, 6008, Australia
  • Investigator Site - Nedlands accepting new patients
    Nedlands, 6009, Australia

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Nektar Therapeutics
ID
NCT02915744
Phase
Phase 3
Lead Scientist
Michelle Melisko
Study Type
Interventional
Last Updated
October 30, 2017
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